NCT02360098

Brief Summary

Smooth emergence (wake up) from anesthesia is an important consideration in patients undergoing neurosurgical procedures as blood pressure changes associated with violent emergence can cause intracranial hemorrhage and brain swelling. At the same time, emergence should also be quick so that patients' neurological function can be assessed at a timely manner. Pattern of emergence from anesthesia is poorly investigated and understood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

February 2, 2015

Results QC Date

May 15, 2020

Last Update Submit

July 10, 2020

Conditions

Keywords

Emergence from AnesthesiaAnterior temporal lobectomyAmygdalohippocampectomyAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Volumes of the Hippocampus, Thalamus and Amygdala

    Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups

    1 day

Interventions

There are no study related interventions in this study and perioperative care of these patients will be as per our standard practice The only study related protocol would be collecting the data on the emergence from anesthesia. The data will be collected from the time of turning off the anesthetic agents till the discharge from recovery room. Data collected include, vital signs, Glasgow coma scale( GCS), and Riker agitation- sedation score.. The patients will be assessed every 5 minutes for the first 30 minutes and every 10 minutes for the next 60 minutes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergence from anesthesia in anterior temporal lobectomy and amygdalohippocampectomy PATIENTS

You may qualify if:

  • Adult patients above the age of 18 who are scheduled for elective anterior temporal lobectomy and amygdalohippocampectomy under General Anesthesia

You may not qualify if:

  • Lack of informed consent Patients needing intensive care unit postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Results Point of Contact

Title
Emad Al Azazi
Organization
TORONTO WESTERN HOSPITAL/UHN

Study Officials

  • Lashmi Venkatraghavan, MD

    Toronto Western Hospital/UHN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 13, 2020

Results First Posted

July 13, 2020

Record last verified: 2020-07

Locations